Data / Medical devices / United States / Magellan Diagnostics, Inc.

Magellan Diagnostics, Inc.: FDA-registered device maker in N Billerica, MA, United States, 4 510(k) clearances

Name: Magellan Diagnostics, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Magellan Diagnostics, Inc. is registered with the FDA (registration 1218996) in N Billerica, MA, United States. It lists 1 device type. The FDA files 4 510(k) clearances under its listings, the newest dated July 7, 2015. 12 recall events name it as the recalling firm (3 Class I). Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch Magellan Diagnostics, Inc.

FDA registration number: 1218996
Address: 101 Billerica Ave Bldg 4, N Billerica, MA, United States, 01862
Owner or operator: MAGELLAN Diagnostics INC. (1218996)
Roles: Manufacturer, Specification developer
First device listed: October 10, 2007
Registered through: 2026
Brand names listed: LeadCare Blood Lead Testing System, LeadCare II Blood Lead Testing Syst, LeadCare Plus, LeadCare Ultra

Devices it lists

Device	Product code	Class	Role	Source
Lead, Atomic Absorption	DOF	2	Manufacturer, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 7, 2015	K142705	LeadCare Plus Blood Lead Testing System	DOF	Substantially Equivalent	Magellan Diagnostics	accessdata.fda.gov
August 20, 2013	K123563	LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM	DOF	Substantially Equivalent	Magellan Diagnostics	accessdata.fda.gov
October 6, 2005	K052549	LEADCARE II BLOOD LEAD TESTING SYSTEM	DOF	Substantially Equivalent	Esa Biosciences, Inc.	accessdata.fda.gov
September 9, 1997	K971640	LEADCARE BLOOD LEAD TESTING SYSTEM	DOF	Substantially Equivalent	Esa, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
September 4, 2026	99776	Class III	Ongoing	LeadCare II Blood Lead Test Kit. Model/Catalog Number: 70-6762.	In kit sub-lot 2530M-01 the date of expiration printed on the outer labeling may indicate the wrong expiration date of July 22, 2026 while the correct expiration date is July 13, 2026. If used the system will display an error message and prevent the operator from running the test. Resulting in delayed results.	accessdata.fda.gov
March 13, 2026	98502	Class II	Ongoing	(1)(2) LeadCare II Blood Lead Test Kit, (3)LeadCare II 5X Blood Lead Test Kit, (4)LeadCare II 9X Blood Lead Test Kit; Catalog Number(s): (1) 70-6762, (2) 70-6762RUO, (3) 70-8404 (Box containing 5 Test Kits), (4) 70-9000	Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems. False positive lead results may cause delayed results and additional unnecessary testing.	accessdata.fda.gov
February 23, 2024	97858	Class II	Ongoing	The LeadCare II Blood Lead Test System relies on electrochemistry and a unique Sensor to detect lead in whole blood. The LeadCare II Test Kit is provided with the following materials: " Sensors (2 Containers of 24 sensor	Calibration Buttons being used in the kitting process were incorrectly labeled as Lot 2323M for lot 2333M. The use of mislabeled calibration Button with Lot #2333 can lead to delayed or erroneous high or erroneous low results.	accessdata.fda.gov
September 19, 2023	93167	Class II	Ongoing	LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only. The test kit is for the quantitative measurement of lead in capillary whole blood.	During an internal audit a small percentage (<10%) of plastic caps used to close the treatment reagent tubes were found to not meet the minimum dimensional lip requirement and may have inadequate cap-to-tube seals. Manufacturing with these caps may result in cap-to-tube seals that allow leaking of HCl or may result in cap-to-tube seals that allow evaporation	accessdata.fda.gov
May 7, 2021	87992	Class I	Terminated	LeadCare II Blood Lead Test Kit Catalog Number 70-6762	Magellan has received reports that control tests of either the Low-Control and/or the High-Control generated a low result. The issue may cause the underestimation of blood lead levels in patient samples.	accessdata.fda.gov
August 8, 2018	81074	Class II	Terminated	Magellan LeadCare II Blood Lead Test Kit. In Vitro Test for the measurement of lead in fresh whole blood. Catalog Number: 70-6762 Primary DI No: 00850355006000 The LeadCare II Blood Lead Test Kit is for in vitro diagnost	Defect with the calibration button for lot 1808M. Level 1 and Level 2 Quality Control (QC) values will generate results of HIGH (>65 g/dL). Results for patient testing with this lot will be displayed as HIGH.	accessdata.fda.gov
January 9, 2018	79279	Class II	Terminated	LeadCare II Blood Lead Analyzer Part Numbers: 70-6760, 70-6529-R, 70-6760-P, 70-6760-R. Intended for in vitro (external) use only.	The incorrect placement of AA batteries into certain LeadCare II Blood Lead Analyzer may cause the batteries to overheat, and the chance that a user could burn their fingers if the batteries are removed while hot.	accessdata.fda.gov
May 23, 2017	77211	Class I	Terminated	Magellan Diagnostics LeadCare and LeadCare II test Kits. Product Usage: The LeadCare Blood Lead Test Kit is for in vitro diagnostic use only. The Test Kit is for the quantitative measurement of lead in fresh whole blood.	Underestimates the lead concentration of venous blood samples when the sample is analyzed with the LeadCare systems	accessdata.fda.gov
January 20, 2016	77695	Class II	Terminated	LeadCare II Blood Lead Test Kit, containing LeadCare II Lead Controls Product Usage: IVD test kit for the detection of lead in blood. The kit consists of sensors, treatment reagent, lead controls (two levels), heparinize	LeadCare II Test Kits controls out of range	accessdata.fda.gov
November 29, 2014	76991	Class I	Terminated	Magellan Diagnostics LeadCare Ultra Blood Analyzer Part Number: 80-0010	LeadCare Plus and LeadCare Ultra Blood Lead Testing Systems may generate falsely low lead concentrations in some blood samples. The issue is observed when blood samples are collected in tubes with lavender and tan rubber stoppers of the Becton Dickinson EDTA Vacutainer tubes, a collection device used with the testing system.	accessdata.fda.gov
September 20, 2007	44909	Not yet classified	Terminated	ESA LeadCare II Blood Test Kit containing Level 1 and Level 2 Control Vials with lot number: 0704A Catalog Number: 70-6762	Level 1 and Level 2 Control values were incorrectly assigned.	accessdata.fda.gov
May 19, 2005	32066	Not yet classified	Terminated	LeadCare Blood Lead Testing System Kits Catalog Number: 70-2233	Lead test results may be reported lower than the actual value	accessdata.fda.gov

Updated October 15, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.